NCT04296604

Brief Summary

In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

11.6 years

First QC Date

February 28, 2020

Last Update Submit

September 4, 2025

Conditions

Keywords

Transcranial Direct Current StimulationExecutive Function

Outcome Measures

Primary Outcomes (1)

  • Change in N-Back Task

    Working Memory Task

    Baseline to Post-Treatment, 1 Week

Secondary Outcomes (5)

  • Change in Flanker Task

    Baseline to Post-Treatment, 1 Week

  • Change in Multi-Source Interference with International Affective Picture System Task

    Baseline to Post-Treatment, 1 Week

  • Change in Delayed Discounting Task

    Baseline to Post-Treatment, 1 Week

  • Change in Stop Signal Task

    Baseline to Post-Treatment, 1 Week

  • Change in Iowa Gambling Task

    Baseline to Post-Treatment, 1 Week

Study Arms (8)

Traumatic Brain Injury

EXPERIMENTAL

This group consists of individuals diagnosed with traumatic brain injury. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Device: Transcranial Direct Current Stimulation

Major Depressive Disorder

EXPERIMENTAL

This group consists of individuals diagnosed with major depressive disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Device: Transcranial Direct Current Stimulation

Bipolar Disorder

EXPERIMENTAL

This group consists of individuals diagnosed with bipolar disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Device: Transcranial Direct Current Stimulation

Schizophrenia

EXPERIMENTAL

This group consists of individuals diagnosed with schizophrenia. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Device: Transcranial Direct Current Stimulation

Attention Deficit Hyperactivity Disorder

EXPERIMENTAL

This group consists of individuals diagnosed with attention deficit hyperactivity disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Device: Transcranial Direct Current Stimulation

Borderline Personality Disorder

EXPERIMENTAL

This group consists of individuals diagnosed with borderline personality disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Device: Transcranial Direct Current Stimulation

Substance Use Disorder

EXPERIMENTAL

This group consists of individuals diagnosed with substance use disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Device: Transcranial Direct Current Stimulation

Healthy Controls

ACTIVE COMPARATOR

This group consists of individuals diagnosed with healthy controls. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.

Device: Transcranial Direct Current Stimulation

Interventions

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Also known as: tDCS
Attention Deficit Hyperactivity DisorderBipolar DisorderBorderline Personality DisorderHealthy ControlsMajor Depressive DisorderSchizophreniaSubstance Use DisorderTraumatic Brain Injury

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female outpatients 18-65 years of age
  • A diagnosis of traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorders meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

You may not qualify if:

  • Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, shunts, pacemakers, pregnancy.
  • Active substance dependence (except for tobacco and cannabis).
  • Pregnant or nursing females.
  • Inability to participate in testing procedures.
  • Diagnosis of psychiatric of neurological disorder
  • Ongoing treatment with any psychotropic medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticDepressive Disorder, MajorBipolar DisorderSchizophreniaAttention Deficit Disorder with HyperactivityBorderline Personality DisorderSubstance-Related Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesDepressive DisorderMood DisordersMental DisordersBipolar and Related DisordersSchizophrenia Spectrum and Other Psychotic DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersPersonality DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Joan Camprodon, MD, PhD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Camprodon, MD, PhD, MPH

CONTACT

Patricia Cirillo, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 5, 2020

Study Start

September 1, 2014

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations